Human Stakeholders and the Use of Animals in Drug Development

Abstract

Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation‐mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies from journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration (FDA) and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well‐being of pharmaceutical firms.

The Scientific Problems with Using Non-Human Animals to Predict Human Response to Drugs and Disease

“…We acknowledge that the scientific community as a whole is not yet familiar with tsmt; but we are confident that, in time, a consensus will be reached. Kramer and Greek (2018) explain the obstacles that must be overcome to ensure that drug development and the study of diseases are based on sound science. This will require changes to the regulations that currently mandate the use of animal models.…”

“…This will require changes to the regulations that currently mandate the use of animal models. Furthermore, Kramer and Greek (2018) discuss modern techniques that fall under the heading of personalized medicine, which offer treatments and cures that are customized to a patient's individual genetic make-up and, hence, sidestep the significant risks associated with the continued blind reliance on methods arising from the use of animal models.…”

“…The way around this problem of identifying the right predictive value is addressed by Greek and Greek (2004), Greek, Menache and Rice (2012), and , and is summarized by Kramer and Greek (2018). The solution involves the use of human-based research and testing through personalized medicine; that is, matching gene(s) to drugs and disease in each patient.…”

“…While it can be argued that there may be scientifically justified grounds for the use of non-human animals in some contexts, other than those that involve predicting human responses, it is most common to see attempts to justify the use of non-human animals for applications to human health (see Kramer and Greek (2018), for additional discussion of this point). Therefore, it is appropriate to carefully examine the claimed validity of the animal model for predicting human outcomes.…”

How to Evaluate the Science of Non-human Animal Use in Biomedical Research and Testing: A Proposed Format for Debate

“…Thus, the only scientifically valid conclusion is to stop attempting to use animal models to predict outcomes for humans. See Kramer and Greek (2018) for an extensive discussion of the many ways various groups of human stakeholders, including but not limited to patients, are directly harmed by the continued use of animal models. While the vested interests we described earlier have served as an obstacle to acceptance of the fact that animal models do not have predictive value for human responses, the truth has, nevertheless, been acknowledged in the scientific literature, on occasion.…”